Ignite Creation Date:
2024-05-06 @ 6:46 PM
Last Modification Date:
2024-10-26 @ 2:54 PM
Study NCT ID:
NCT05772481
Status:
RECRUITING
Last Update Posted:
2023-08-23
First Post:
2023-02-08
Brief Title:
Interest of PET-MRI in the Evaluation of the Response After Neoadjuvant Treatment of Locally Advanced Rectal Adenocarcinoma
Sponsor:
Institut de cancérologie Strasbourg Europe
Organization:
Institut de cancérologie Strasbourg Europe
Study Overview
Official Title:
Interest of PET-MRI in the Evaluation of the Response After Neoadjuvant Treatment of Locally Advanced Rectal Adenocarcinoma
Status:
RECRUITING
Status Verified Date:
2023-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
TEPIREC
Brief Summary:
With 50 patients included this trial would be the largest pilot study evaluating the value of MRI PET in locally advanced rectal cancer On the other hand it would be the only pilot study performing several MRI PET during neoadjuvant treatment Presumably the response assessed at the 2nd MRI PET before cycle 4 or induction chemotherapy would be predictive of the overall response at the end of neoadjuvant treatment Then it would be possible to predict precociously the tumor response
Detailed Description:
The management of localized rectal cancer is done in two phases The first phase medical combines a possible first chemotherapy followed by a concomitant chemoradiotherapy The second phase 6 to 8 weeks later consists of surgery of the rectum
Magnetic resonance imaging MRI of the pelvis allows staging of the tumor and its possible lymph node extensions MRI can also be used to assess tumor response after the first phase of treatment and before surgery But MRI of the pelvis is partially imperfect
PET-MRI is an examination that combines MRI with an injection of 18 Ffluorodeoxyglucose 18F-FDG It is known to be more sensitive in assessing tumor stage and lymph node extensions compared to MRI and more sensitive in assessing tumor response before surgery
The aim of this study is to determine predictive parameters for response to the first phase of treatment by accurately identifying the characteristics of tumors that have responded or not to treatment with chemotherapy and chemoradiotherapy
Magnetic resonance imaging MRI of the pelvis allows staging of the tumor and its possible lymph node extensions MRI can also be used to assess tumor response after the first phase of treatment and before surgery But MRI of the pelvis is partially imperfect
PET-MRI is an examination that combines MRI with an injection of 18 Ffluorodeoxyglucose 18F-FDG It is known to be more sensitive in assessing tumor stage and lymph node extensions compared to MRI and more sensitive in assessing tumor response before surgery
The aim of this study is to determine predictive parameters for response to the first phase of treatment by accurately identifying the characteristics of tumors that have responded or not to treatment with chemotherapy and chemoradiotherapy
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None